#United States #TREMFYA® #Johnson & Johnson #New Brunswick #Crohn's Disease

TREMFYA® Proves Effective for Crohn's Disease Treatment

Johnson & Johnson has announced groundbreaking data regarding TREMFYA® (guselkumab), the only IL-23 inhibitor that can be administered entirely via subcutaneous injections. Recent findings presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG) highlighted the drug's remarkable ability to maintain durable clinical remission in patients suffering from moderately to severely active Crohn's disease over a two-year span.

Key Findings from the Study

The latest data released comes from the long-term extensions (LTE) of the Phase 3 studies known as GRAVITI, GALAXI 2, and GALAXI 3. After 96 weeks of treatment, clinical remission rates were reported at an impressive over 85% for patients undergoing the maintenance doses of TREMFYA®. This efficacy was evaluated among two administrative regimens: 100 mg every eight weeks or 200 mg every four weeks. Noteworthy results were:

• - Clinical Remission Rates: 92.0% and 86.7% for the two different regimens, respectively.
• - Endoscopic Response: Approximately 65.1% and 70.7%.
• - Endoscopic Remission: Ranged from 41.5% to 56.6%, showing substantial healing of the intestinal lining.
• - Deep Remission: Achieved in 38.7% to 51.2% of participants.

These findings strongly affirm the long-term efficacy of TREMFYA®, which establishes it as an effective treatment option for individuals struggling with Crohn's disease.

Understanding TREMFYA®

TREMFYA® is classified as a dual-acting monoclonal antibody that uniquely targets and blocks the inflammation pathway by inhibiting IL-23—a crucial cytokine involved in immune responses. Additionally, it binds to CD64, a receptor found on cells that generate IL-23. This multifaceted approach is intended to control the inflammation characteristic of autoimmune diseases like Crohn's disease.

Dr. David Rubin, who is the Director of the Inflammatory Bowel Disease Center at the University of Chicago, remarked, "Crohn's disease can significantly impact quality of life. Thus, the results indicate that TREMFYA® facilitates better management of the condition, allowing patients to gain more independence and confidence in their treatment regimens."

The study further emphasizes that, unlike previous treatments, TREMFYA® is tailored for subcutaneous administration and also has an intravenous (IV) option. This flexibility provides patients with various ways to initiate their treatments, personalized to their needs.

Safety Profile

The safety profile observed throughout the 96-week period was consistent with previously established data about TREMFYA®. Patients receiving this treatment will continue to be monitored for any adverse effects, especially concerning potential risks associated with infections and allergic reactions. Importantly, those starting treatment will have thorough screenings for infections and tuberculosis (TB) before they initiate TREMFYA® therapy.

An Innovative Option in IBD Treatment

TREMFYA®'s FDA approval signifies a substantial milestone as the only IL-23 inhibitor approved for treatment in both Crohn's disease and ulcerative colitis. This expanded applicability enhances the treatment options for patients and providers alike.

As noted by Dr. Esi Lamousé-Smith, Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson, "The availability of both subcutaneous and IV induction methods means that TREMFYA® can cater to a variety of patient needs. The results reinforce our commitment to providing innovative treatments that deliver long-term improvements to individuals battling inflammatory bowel diseases."

Conclusion

This recent research cements TREMFYA®'s standing as a crucial addition to the therapeutic arsenal against Crohn's disease, underlining not only its efficacy but also its flexibility in treatment protocols. With the ongoing evaluation of its safety and effectiveness, patients can look forward to greater autonomy and confidence in managing their condition. The findings presented are a promising beacon for those impacted by chronic inflammatory bowel diseases, marking a hopeful step toward enhancing patient quality of life.

For further details on TREMFYA® and ongoing research, visit Johnson & Johnson.